Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Ranbaxy Ireland Limited
8 Milligram
Tablets
2010-11-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan cilexetil 8mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg candesartan cilexetil. Excipient: 75.8 mg of lactose monhydrate/tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pink capsule shaped tablet with ‘C’ & ‘10’ debossed on either side of breakline on one side and breakline on other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CANDESARTAN CILEXETIL is indicated for the: • Treatment of essential hypertension in adults. • Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY IN HYPERTENSION The recommended initial dose and usual maintenance dose of CANDESARTAN CILEXETIL is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response. CANDESARTAN CILEXETIL may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of CANDESARTAN CILEXETIL. _Elderly population_ No initial dosage adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with po Prečítajte si celý dokument